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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03140631
Other study ID # HUM00117851
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 23, 2017
Est. completion date April 3, 2018

Study information

Verified date September 2018
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety, efficacy and efficiency of rapid anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT) monitoring in patients undergoing catheter based ablation of atrial fibrillation.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date April 3, 2018
Est. primary completion date November 16, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial fibrillation or atrial flutter (left atrial).

- Age = 18 year

- Patients who are mentally and linguistically able to understand the aim of the trial, comply with the trial protocol, verbally acknowledge the risks, benefits, and alternatives in this trial.

Exclusion Criteria:

- Previous intolerance or allergy to heparin products.

- Current or prior administration of protamine products

- History of femoral access site complications including hematoma, AV fistula, pseudoaneurysm, aneurysm.

- Known lower extremity venous thrombosis.

- Coagulopathy or blood dyscrasias.

- Active malignancy.

- Thrombocytosis (platelet count >600k/ul) or thrombocytopenia (platelet count <100k/ul)

- Planned use of vascular closure device

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Protamine Sulfate
Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.

Locations

Country Name City State
United States Michigan Medicine Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Ambulation Total length of time from procedural termination to patient ambulation 0 to 24 hours
Secondary Count of Participants Who Experienced Vascular Access Site Complications Secondary endpoints will include the number of patients who experience a 90-day occurrence of vascular access site complications defined as hematoma formation, aneurysm, pseudoaneurysm, arteriovenous fistula formation, access-site related major bleeding (defined as Bleeding Academic Research Consortium (BARC) type 3a or 5), or procedural intervention for access complications (surgical repair, thrombin injection, et cetera) checked at 30 and 90 days
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